Nasal dilator with means to direct resilient properties

ABSTRACT

A nasal dilator comprises a laminate of vertical layers each consisting of one or more members or components. The laminated layers form a unitary, or single body, truss featuring horizontal regions adapted to engage outer wall tissues of first and second nasal passages and to traverse the bridge of a nose therebetween. When in use the dilator acts to stabilize and/or expand the nasal outer wall tissues and prevent said tissues from drawing inward during breathing. The dilator includes means to direct its resilient properties comprising one or more interior or exterior material separations, or discontinuity of shape of material, formed in at least one region of the truss and extending through at least one layer of the dilator. Said material separation or discontinuity of shape may comprise an opening, relief cut, slit or notch, and which may be configured to separate or vertically protrude, in part, from the truss when the dilator is in use on the nose of a wearer. Said separation or vertical protrusion changes the angle of focused delaminating spring biasing forces generated by the resilient layer, transforming said forces, at least in part, from primarily peel forces into primarily shear forces, and further redistributing or imparting said transformed forces to tissue engaging surface areas extending outward and beyond said material separation.

RELATED APPLICATIONS

This application is a CONTINUATION of Nonprovisional patent applicationSer. No. 13/866,008 filed 18 Apr. 2013, now U.S. Pat. No. 9,364,368which was a CONTINUATION of Nonprovisional patent application Ser. No.13/206,462 filed 9 Aug. 2011, now U.S. Pat. No. 8,444,670, which is aCONTINUATION of Nonprovisional patent application Ser. No. 12/106,289filed 19 Apr. 2008, now U.S. Pat. No. 8,062,329, which claims prioritybenefit of Provisional Patent Application No. 60/913,271 filed 21 Apr.2007.

FIELD OF THE INVENTION

The present invention relates to apparatus and methods of dilatingexternal tissue. As disclosed and taught in the preferred embodiments,the tissue dilator devices are particularly suitable for use as externalnasal dilators for supporting, stabilizing, and dilating nasal tissuesadjacent and overlying nasal airway passages, including the nasal valveand/or the vestibule areas thereof.

BACKGROUND OF THE INVENTION

A portion of the human population has some malformation of the nasalpassages which interferes with breathing, including deviated septa andswelling due to allergic reactions. A portion of the interior nasalpassage wall may draw in during inhalation to substantially block theflow of air through the nasal passage. Blockage of the nasal passages asa result of malformation, symptoms of the common cold or seasonalallergies are particularly uncomfortable at night, and can lead to sleepdisturbances, irregularities and general discomfort.

Spring-based devices for dilating outer wall tissues of the human noseadjacent the nasal passages have a history spanning over one hundredyears. The spring-based concept uses resilient means which flex acrossthe bridge of the nose together with means to engage the nasal passageouter walls from either the interior mucosa or exterior epidermis sidesthereof and thus stabilize or urge outwardly the nasal outer walltissue. Some examples of present external nasal dilators are disclosedin U.S. Pat. No. 6,453,901; D379,513; D429,332; D430,295; D432,652;D434,146; D437,64; and Japanese patent Reg. No. 1037944; the entiredisclosures of which are incorporated herein by reference. Thecommercial success of at least one of these inventions, together withthat of other modern external nasal dilators, collectively and commonlyreferred to as nasal strips, has led to the creation and establishmentof a nasal dilator product category in the present consumer retailmarketplace. Commercial success of prior art nasal dilator devicesdisclosed before 1990, in particular that of U.S. Pat. No. 1,292,083(circa 1919), is presumed to be commensurate with the nature of consumerproduct retail environments at the time of those inventions.

Throughout the history of those medical devices which engage externalbodily tissue (i.e., tissue dilators, nasal splints, ostomy devices,surgical drapes, etc.), a long-standing practice in the construction anduse thereof has been to interpose a buffer material between the deviceand the user's skin to facilitate engagement of the device to the skinand to aid user comfort. Said material, such as a spunlaced polyesternonwoven fabric, typically has properties which permit limited,primarily plastic and somewhat elastic deformation within the thicknessthereof. These properties can spread out peeling, separating ordelaminating forces such as may be caused by gravity acting on theweight of the device; the device's own spring biasing force or rigidity(such as that of a tissue dilator or nasal splint); biasing force thatmay be present in bodily tissue engaged by the device; surfaceconfiguration differences between the device and the skin of the devicewearer; displacement of the device relative to the skin or externaltissue as a result of shear, tensile, cleavage and/or peel forcesimparted thereat via wearer movement (e.g., facial gestures) and/orcontact with an object (e.g., clothing, pillow, bedding, etc.); and soon, that may cause partial or premature detachment of the device fromthe wearer. By spreading out these delaminating forces, said interfacematerial acts as a buffering agent to prevent the transfer of saidforces to its adhesive substance, if any, and thereby to the skin.Preventing the transfer of focused delaminating forces substantiallyeliminates any itching sensation (caused by the separation of theadhesive substance or device from the skin) that a wearer may experienceif these delaminating forces were otherwise imparted directly to theskin.

There has been a continuing need in the art to develop nasal dilatorswhich address and improve upon the dynamics and design parametersassociated with limited skin surface area adjacent the nasal passages,adhesive attachment, delaminating spring biasing forces, device comfort,and durational longevity.

Firstly, tissues associated with and adjacent the nasal passages havelimited skin surface areas to which dilation may be applied. Saidsurfaces extend upward from the nostril opening to the cartilage justabove the nasal valve, and extend outward from the bridge of the nose toeach approximate line where the sides of the nose meet each cheek.

Secondly, nasal dilators are, of necessity, releasably secured to saidskin surfaces by use of pressure sensitive adhesives. Skin surfacestransmit moisture vapor to the surrounding atmosphere. Said adhesivesbreak down in the presence of skin oils, moisture and the transmissionof moisture vapor, often within hours.

Thirdly, the functional element of present and historic spring-basednasal dilator devices designed to engage and stabilize and/or expandnasal outer wall tissue is a semi-rigid resilient member which extendsbeyond each side of the bridge of the nose adjacent the nostrils.External nasal dilator devices of the present modern era feature a flat,substantially rectangular or slightly arcuate resilient member made ofplastic. When engaged to a nose, the resilient member exerts a springbiasing force which tends to substantially return or restore the deviceto an original, generally planar, state thus dilating the local tissue.Said spring biasing force creates primarily peel and some tensile forcesgenerated at the end regions of the device where engaged to the nose ofa wearer. Said forces work to delaminate the end regions of the dilatordevice from skin surfaces so engaged.

Constructing a device with less than 10 grams of spring biasing force inorder to mitigate delaminating peel forces may not provide suitablestabilization to, or dilation of, nasal outer wall tissues.Over-engineering the dilator by using a more aggressive adhesive, agreater amount of adhesive, or greater adhesive surface area in order towithstand greater spring biasing force increases the likelihood of userdiscomfort during use and damage to the tissue upon removal of thedevice. Additionally, a dilating spring biasing force of 40 grams ormore could, in and of itself, be uncomfortable for most users.

Presently known spring-based nasal dilator devices which are suitable oradaptable for mass commercialization in the present consumer retailmarket typically fall within a range of dimensions of 5.0 to 7.5 cm(2.0″ to 3.0″) in length and 1.2 to 2.5 cm (0.5″ to 1.0″) in width.Resilient members are typically from about 4.2 to 5.8 cm (1.7″ to 2.3″)long, approximately 0.048 to 0.12 cm (0.12″ to 0.30″) wide and typically0.010″ thick. A resilient member thickness of more or less than 0.010″is not common in the art, but may be incorporated with proportionateadjustments to width and length. Examples include devices disclosed inU.S. Pat. No. D379,513; 5,533,503; 5,546,929; RE35408; 6,453,901;7,114,495; and Spanish Utility Model 289-561 for Orthopaedic Adhesive.These devices provide sufficient dilation of nasal passage outer walltissues and thus provide the claimed benefit to the vast majority ofusers. In addition, the '503 and '901 disclosures teach means forshifting, transforming and redistributing delaminating peel and tensileforces into primarily shear forces. Said shifting or transforming isdesirable since the pressure sensitive adhesive disposed on nasaldilator devices for engaging skin surfaces adjacent the nasal passageswithstand shear forces generally better, longer and more reliably thanpeel forces.

The '503 device features a complicated structure at the device lateralend edges whereby to shift, transform or redistribute said delaminatingpeel and tensile forces. Said structure includes first and secondparallel, spaced apart, resilient spring bands with identical scallopedend edges forming upper and lower protrusions separated by a valley. Theextent of said protrusions are defined by the respective ends of theresilient bands. Outboard and adjacent said upper and lower protrusionsare respective upper and lower extensions separated from saidprotrusions by upper and lower back cuts. Said extensions extend pastsaid protrusions. The '503 specification teaches that the constituentfeatures of this end edge structure combine to effectively minimizessignificant inadvertent peeling of the device end regions from the outerwall tissue of the nasal passages as a result of the discontinuity ofshape of the materials at the intersection of said protrusions and saidextensions, as defined by said back cuts, and redistributes andtransforms peeling and tensile delaminating forces into primarily shearforces which are imparted to said upper and lower extensions extendingbeyond said back cuts.

The '901 disclosure teaches a simpler end region structure whichincludes relief cuts placed adjacent each terminal end of a singleresilient spring band, extending around its terminal ends and slightlyalong the upper and lower longitudinal edges thereof, corresponding tothe general outline of the terminal ends of the resilient band withoutcontact thereto. When in use on the nose of a wearer, this structureshifts peel and tensile delaminating forces into primarily shear forceswhich are imparted to the material extending between said relief cutsand the lateral end edges of the device.

U.S. Pat. No. 5,611,333 discloses a dilator device which featuresvarious openings, slits, notches and cuts formed within the peripheraledges of a resilient member whereby to selectively reduce spring biasingforces locally so that the resilient member may be used as a stand alonedilator device without the use of additional materials for maintainingthe dilator device engaged to the nose of a wearer.

The present invention builds upon the prior art by providing means todirect the resilient properties of a nasal dilator whereby to overcomethe aforementioned dynamics and design parameters associated withexternal dilation of nasal outer wall tissues.

SUMMARY OF THE INVENTION

The present invention teaches, depicts, enables, illustrates, describesand claims new, useful and non-obvious apparatus and methods ofproviding dilation to external tissue. In particular, the presentinvention provides a wide variety of tissue dilators adapted to engagean exterior tissue region of a nose to dilate the nasal passages thereofincluding the vestibule and/or nasal valve areas. It is the principalobjective of the present invention to provide nasal dilator deviceswhich improve and build upon the prior art and address unmet needs inthe art.

In the specification and claims herein, the term vertical refers to adirection parallel to the thickness of the dilator or truss. The termhorizontal refers to a direction parallel to the length, or longitudinalextent, or long axis of the dilator or truss. The term lateral refers tothe width or opposing end edges of the dilator or truss, or a directionperpendicular to the length, longitudinal extent, or long axis of thedilator or truss. The term longitudinal centerline refers to a lineparallel to the longitudinal extent of the dilator or truss, bisectingthe width of the dilator or truss midway between its upper and lowerlong edges. The term lateral centerline refers to a line perpendicularto the length, longitudinal extent, or long axis of the dilator ortruss, bisecting the long axis, or upper and lower long edges, midwayalong the length thereof.

The external nasal dilator of the present invention comprises a laminateof vertical layers. The laminated layers form a unitary, or single body,truss with each layer consisting of one or more members and/orcomponents. The layers preferably include a base layer, resilient layer,and cover layer. Any single layer, or a combination of two or morelayers may define the peripheral shape or edges of the dilator. Thedilator is die cut from a continuous laminate of material layers, anddilator members or components may be die cut, in whole or part, from oneor more continuous material layers before or during assembly of thecontinuous laminate. The truss features horizontal regions includingfirst and second end regions adapted to engage outer wall tissues offirst and second nasal passages, respectively, and an intermediateregion adapted to traverse a portion of a nose located between the firstand second nasal passages and joining the end regions. In use thedilator acts to stabilize and/or expand the nasal outer wall tissues andprevent said tissues from drawing inward during breathing.

Embodiments of the nasal dilator of the present invention include,without limitation, new and non-obvious means to direct the resilientproperties thereof. Said means include one or more material separations,or discontinuity of shape of material, formed within the peripheraledges of the truss (an interior material separation), and may includeone or more material separations or discontinuity of shape of materialextending inward from a peripheral edge of the truss (an exteriormaterial separation). Said material separations may be formed before,during or after the peripheral shape of the dilator is die cut from theaforementioned continuous laminate of materials. An interior materialseparation may also include forming, modifying or configuring at least aportion of the resilient layer before assembling the constituent layersof the dilator into the vertical laminate. Said formation, modificationor configuration may include forming the peripheral shape of theresilient member, such as gradiently tapering its width, or may includeforming component extensions such as spring fingers, or may includeinterior or exterior material separations, such as a cut, opening ornotch, as described above with respect to the truss, but made to theresilient member alone.

An interior material separation may form a flap capable of separating orvertically protruding, in part, from the truss when the dilator isflexed across the nose of a wearer. Similarly, an exterior materialseparation may form a horizontal protrusion, also capable of separating,in part, from the truss when the dilator is flexed across the nose of awearer. In either case, said separation or vertical protrusion changesthe angle of focused spring biasing forces, at least in part, and thusshifts or transforms at least some of said forces from primarily peeland tensile forces to primarily shear forces. Said change in anglefurther redistributes or imparts said transformed forces to tissueengaging surface areas extending beyond the material separation. Thus,spring biasing forces may be distributed to the potentially largersurface area of the dilator end regions, as opposed to a greaterdelaminating tendency, such as that from peel forces, being imparted toa smaller surface area. Said potential larger surface area is as aresult of the configuration of the end regions of the truss and/or theconfiguration of the respective layers of the dilator. The effect ofmaterial separations can lessen overall delaminating forces withoutreducing the spring biasing force of the dilator, in that shear forcesare more easily withstood by the tissue engaging adhesives typicallydisposed on the tissue engaging surfaces of the dilator. Accordingly, alesser amount of adhesive and/or less aggressive adhesive (and thus lesscostly) disposed on the tissue engaging surfaces of the dilator would,in addition, be more comfortable to the user and more easily removedfrom the tissue so engaged. An opposing pair of said material separationmay be spaced apart along the longitudinal centerline of the truss.

An interior material separation extending vertically through thedilator, including the resilient layer, may also form a flap capable ofseparating or vertically protruding, in part, from the resilient layer.Said separation or vertical protrusion may also change, at least inpart, the angle of spring biasing forces thereof, while allowing springbiasing forces to continue along a further extent of the resilientmember or component. Said interior material separation may be confinedwithin the peripheral edges of the resilient layer material or,alternatively, may sever the resilient member from one long edge thereofand extend across a portion of its width.

Means to direct resilient properties thus also include a dynamicrelationship between the effects of interior and exterior materialseparations, including the degree of horizontal spacing between anopposing pair thereof, and any other modification to, or configurationof, the resilient layer, such as its peripheral shape or the inclusionof additional material separations made thereto.

The preferred embodiments of the present invention further include atruss with means for horizontally aligning the dilator to the nose of awearer comprising a positioning aid located at the intermediate regionforming a separation, projection or other index marker; means to spreadthe spring biasing force of resilient layer to a greater, primarilylateral, surface area of dilator, and means to prevent one or morematerial separations from separating in part from the truss. This lattermeans may also be used to extend or increase the tissue engaging surfacearea of the truss.

The skilled man in the art will appreciate the applicability of thecontinually developing art of medical device converting; specifically,continuous rotary laminating and die cutting, and flatbed and class Atool die cutting and punching.

The present invention is not limited to the illustrated or describedembodiments as these are intended to assist the reader in understandingthe subject matter of the invention. The preferred embodiments areexamples of forms of the invention comprehended by the devices taught,enabled, described, illustrated and claimed herein. All structures andmethods which embody similar functionality are intended to be coveredhereby. In certain instances, the devices depicted, taught, enabled anddisclosed herein represent families of new, useful and non-obvioustissue dilators having a variety of alternate embodiments. The skilledman will appreciate that features, devices, elements, members orcomponents thereof, methods, processes or techniques may be applied,interchanged, eliminated in whole or part, or combined from oneembodiment to another. Dilator members or components thereof, materials,layers or regions may be of differing size, area, thickness, length orshape than that illustrated or described while still remaining withinthe purview and scope of the present invention. The preferredembodiments include, without limitation, the following numbered,discrete forms of the invention, as more fully described below.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING

In the drawings which accompany this disclosure, like elements arereferred to with common reference numerals. Drawings are not rendered toscale.

FIG. 1 is an exploded perspective view of a nasal dilator in accordancewith the present invention.

FIG. 2 is a perspective view of the nasal dilator of FIG. 1.

FIG. 3 is a plan view of the nasal dilator of FIG. 1.

FIG. 4 is a fragmentary plan view, on an enlarged scale, illustratingone end region of the nasal dilator of FIG. 3.

FIG. 5 is a perspective view of a portion of a face with the nasaldilator of FIG. 1. secured to the nose.

FIG. 6 is a front elevation view of the nasal dilator of FIG. 5 securedto the nose, seen as a portion of a face, of a wearer.

FIG. 7 is a is a fragmentary perspective view, on an enlarged scale, ofthe dilator of FIG. 5 secured to the nose of a wearer.

FIG. 8 is a plan view of a variation of the nasal dilator of FIG. 1.

FIG. 9 is a fragmentary plan view, on an enlarged scale, illustratingone end region of the nasal dilator of FIG. 8.

FIG. 10 is a fragmentary plan view, on an enlarged scale, illustratingan alternative end region structure to that of the nasal dilator of FIG.9.

FIG. 11 is a plan view of an alternative form of nasal dilator embodyingfeatures of the present invention.

FIG. 12 is a fragmentary plan view, on an enlarged scale, illustratingone end region of the nasal dilator of FIG. 11.

FIG. 13 is a plan view of an alternative form of nasal dilator embodyingfeatures of the present invention.

FIG. 14 is a fragmentary plan view, on an enlarged scale, illustratingone end region of the nasal dilator of FIG. 13.

FIG. 15 is a fragmentary plan view, on an enlarged scale, illustratingan alternative end region structure to that of the nasal dilator of FIG.14.

FIG. 16 is a plan view of an alternative form of nasal dilator embodyingfeatures of the present invention.

FIG. 17 is a fragmentary plan view, on an enlarged scale, illustratingone end region of the nasal dilator of FIG. 16.

FIG. 18 is a plan view of an alternative form of nasal dilator embodyingfeatures of the present invention.

FIG. 19 is a fragmentary plan view, on an enlarged scale, illustrating aportion of one end region of the nasal dilator of FIG. 18.

FIG. 20 is a plan view of an alternative form of nasal dilator embodyingfeatures of the present invention.

FIG. 21 is a fragmentary plan view, on an enlarged scale, illustrating aportion of one end region of the nasal dilator of FIG. 20.

FIG. 22 is a plan view of an alternative form of nasal dilator embodyingfeatures of the present invention.

FIG. 23 is a fragmentary plan view, on an enlarged scale, illustratingone end region of the nasal dilator of FIG. 22.

FIG. 24 is a plan view of an alternative form of nasal dilator embodyingfeatures of the present invention.

FIG. 25 is a fragmentary plan view, on an enlarged scale, illustrating aportion of one end region of the nasal dilator of FIG. 24.

FIG. 26 is a plan view of an alternative form of nasal dilator embodyingfeatures of the present invention.

FIG. 27 is a fragmentary plan view, on an enlarged scale, illustrating aportion of one end region of the nasal dilator of FIG. 26.

FIG. 28 is an exploded perspective view of the nasal dilator of FIG. 26.

FIG. 29 is a plan view of an alternative form of nasal dilator embodyingfeatures of the present invention.

FIG. 30 is a fragmentary plan view, on an enlarged scale, illustrating aportion of one end region of the nasal dilator of FIG. 29.

FIG. 31 is a front elevation view of the nasal dilator of FIG. 29secured to a nose, seen as a portion of a face, of a wearer.

FIG. 32 is an exploded perspective view of the nasal dilator of FIG. 29including additional end region components.

FIG. 33 is a plan view of an alternative form of nasal dilator embodyingfeatures of the present invention.

FIG. 34 is a fragmentary plan view, on an enlarged scale, illustrating aportion of one end region of the nasal dilator of FIG. 33.

DETAILED DESCRIPTION OF THE INVENTION

An embodiment of a nasal dilator, 10, in accordance with the presentinvention is illustrated in FIG. 1. Dilator 10 comprises a verticallaminate of material layers including: a base layer composed of at leastone base member, 14, including components thereof; a resilient layercomprised of at least one resilient member, 22, including componentsthereof and a cover layer composed of at least one cover member, 18,including components thereof. A protective layer of release paper liner,15, removably covers any exposed adhesive from any layer preliminary touse of dilator 10 on the nose of a wearer. The periphery of releaseliner 15 may correspond to the periphery of dilator 10 or a peripheryexceeding one or more dilators 10. The components or layers of dilator10 are preferably aligned along their longitudinal centerlines.

The preferred material for the base and cover layers is from a group ofwidely available flexible nonwoven synthetic fabrics that allow the skinon user nose 11 to exchange gases with the atmosphere and to maximizecomfort of dilator 10 thereon. Alternatively, any suitable fabric orplastic film may be used. A continuous pressure sensitive adhesivesubstance, biocompatible with external human tissue, is disposed on atleast one flat surface side of said material which is the adhesive side,opposite the non-adhesive side. The non-adhesive side is typicallyopposite the skin engaging side. A protective layer of continuousrelease paper liner covers said adhesive. Said materials are typicallyavailable in continuous rolls wound in a machine direction (MD) or warp,which is perpendicular to the cross direction (XD) or fill, of thefabric. The base and cover layers of dilator 10 may be fabricatedparallel to either the warp or the fill of said fabrics. The preferredmaterial for the resilient layer is a biaxially oriented polyester resin(PET). PET has suitable spring biasing properties both MD and XD, and iswidely available under trade names such as Mylar® and Melinex® in avariety of standard thickness including 0.005″, 0.007″, and 0.010″.

The width, length and peripheral outline or edges of dilator 10 may bedefined by the base layer, cover layer, or a combination of any two ormore layers or portions thereof. The base and cover layers of dilator 10may have like or dissimilar dimensions or peripheral edges, in whole orin part, compared to each other. Their respective peripheral shapes maybe uniform or non-uniform, and may also be of like or dissimilar size orscale. Portions of any layer may define a horizontal region of thedilator or a portion thereof. Furthermore, the base and cover layers ofdilator 10 may be interchanged, or either the base layer or cover layermay be optionally eliminated in whole or in part. The base and resilientlayers may have identical peripheral edges, and thus may be formed as asingle unit. Portions of one or both flat surfaces of any layer, memberor component thereof, may overlap portions of any flat surface ofanother layer. Preferably, however, the base layer acts as a buffer inengaging the user's skin, as described hereinbefore with respect tomedical devices, and portions of one or more dilator layers may engagenasal outer wall tissues simultaneously. When engaged on the nose of awearer, preferably no portion of a layer extends substantially over askin surface area beyond those surface areas associated with the nasalpassages as described hereinbefore.

As illustrated in FIG. 2, the laminated layers of dilator 10 form aunitary, or single body, truss, 30, having horizontal regions asindicated by bracketed broken lines. Truss 30 includes a first endregion, 32, a second end region, 34, and an intermediate region, 36,interconnecting first end region 32 to second end region 34. The layers,members or components of dilator 10 may overlap or extend from theiroriginating region to an adjacent region. End regions 32 and 34 areadapted to engage outer wall tissues of first and second nasal passages,respectively. The width of each end region is preferably greater thanthe width of respective portions or components of resilient member 22extending horizontally therein. End regions 32 and 34 include lateralend edges, 33 a and 33 b, respectively, which define the outer, lateralends of truss 30 and thus dilator 10. End edges 33 a and 33 b may beangled inward in a straight line between upper and lower corners of thelong edges of dilator 10, said angle corresponding approximately to theline where the nose meets the cheek. The width of intermediate region 36is preferably narrower than the width of end regions 32 and 34,preferably without resilient member 22 being formed narrower at its midsection that at its outer ends as a result.

Finished dilators 10 are typically die cut from a continuous laminate ofmaterial layers. However, dilator layers, members or components thereof,material separations or horizontal regions of truss 30 may be formed ordie cut, in whole or part, from one or more of continuous materialsbefore, or during, assembly of the material laminate from which finisheddilators 10 are die cut. In fabricating dilators 10, end regions 32 and34 are preferably formed as mirror images of each other. However,asymmetric or non-identical end region configurations have the advantageof providing disparate dilating forces and tissue engaging surface areasto opposing nasal outer wall tissues, and thus more accurate orcustomized dilation or stabilization to the respective nasal passages.It will thus be obvious to the skilled man that virtually any two endregion structures of the preferred embodiments herein may beintentionally combined in a given dilator device. For the sake ofclarity and simplicity, however, the preferred embodiments illustrateend regions 32 and 34 as mirror images of each other. Additionally,certain of the enlarged fragmentary plan views refer to features of endregion 34, but are equally applicable to end region 32.

When engaged to and flexed across a nose 11, dilator 10, through itsresilient means as a result of its constituent members and layerscombined to form single body truss 30, acts to stabilize and/or expandthe nasal outer wall tissues and prevent said tissues from drawinginward during breathing.

Dilator 10 includes resilient means having resilient properties providedthrough its resilient layer and configured to provide suitable springreturn biasing force as described hereinbefore. Overall spring biasingforce is generally determined by the width, length, and thickness of atleast one resilient member 22 or the resilient layer as a whole from itsconstituent member(s) and/or components. Resilient member 22 preferablyhas an adhesive substance disposed on at least a portion of at least oneof two opposite flat surface sides for engaging or laminating it toother layers, members or components of dilator 10 or for engaging theskin surface of the nose. Resilient member 22 has opposite terminalends, 23 a and 23 b, respectively, that may conform to at least portionsof the lateral end edges 33 a and 33 b of dilator 10. Terminal ends 23 aand 23 b may extend to one or both of said lateral end edges of dilator10, or may extend short of one or both end edges.

Dilator 10 includes means to direct its resilient properties. Said meansmay comprise configuration of or modification to, the resilient layer orthe material from which the resilient layer is formed. Saidconfiguration or modification may be made either in the course offorming resilient member 22, or may be made to the resilient layermaterial separately, or at the time said material is assembled into thecontinuous material laminate from which dilator 10 is die cut (i.e., atthe time the vertical laminate of dilator 10 is formed). Saidconfiguration or modification may include cuts, notches, openings, orthe like formed in the resilient layer material; or by varying thefinished dimensions of the resilient member or a component thereof, suchas by forming a gradiently tapered width; or by peripheral shape of theresilient member, such as by extensions or divergent spring fingercomponents extending outward from its longitudinal extent; or by morethan one resilient member, each member contributing a portion of thetotal spring biasing force. Having divergent spring fingers or multipleresilient members may increase the effective surface area subject toresilient layer spring biasing forces by spreading those forces to agreater, primarily lateral, surface area of dilator 10.

Said means to direct the resilient properties of dilator 10 furthercomprises at least one separation or discontinuity of shape of materialof one or more regions or layers of truss 30. Said material separationor discontinuity of shape comprises a relief cut or back cut, slit,opening, notch, or the like, having a lateral and/or longitudinalextent, formed within the peripheral edges of dilator 10 (an interiormaterial separation), or extending inward from a peripheral edge thereof(an exterior material separation). Said material separation extendsvertically through at least one layer of dilator 10 and may optionallyextend through release liner 15. An interior material separationextending across the width of the resilient member 22 redefines itsfunctional length (said function being the creation of spring biasingforces when flexed), and thus changes the dimensional relationshipbetween its length and width/thickness. This also changes the spatial,dimensional relationship between the functional portion of the resilientlayer and the other members or layers of dilator 10. Said interiormaterial separation thus further creates and defines at least oneadditional, substantially nonfunctional, component of the resilientlayer.

One or more opposing pairs of interior or exterior material separationsmay be placed within or near respective end regions 32 and 34 of truss30. An opposing pair is preferably positioned in a spaced apartrelationship along or near the dilator's longitudinal centerline. Thespacing apart of a pair of material separations is dynamic, anddetermines, at least in part, some degree of direction of resilientproperties, as well as the longitudinal extent of dilator 10 affectedthereby. Said means to direct resilient properties thus furthercomprises a dynamic relationship between the effect of an opposing pairof material separations and any other modification to, or configurationof the resilient layer, including additional material separations orpairs thereof. For the sake of clarity and simplicity, interior andexterior material separations are shown uniform or as mirror images ofeach other in the preferred embodiments illustrated herein. Aspreviously noted, however, asymmetric or non-identical elementalconfigurations have the advantage of providing disparate dilating forcesand tissue engaging surface areas to opposing nasal outer wall tissues,and thus more accurate or customized dilation or stabilization to therespective nasal passages. Accordingly, it will be obvious to theskilled man that disparate material separations may be intentionallycombined in a given dilator device, or identical or opposing materialseparations may be of dissimilar size or scale. Additionally, certain ofthe enlarged fragmentary plan views illustrate material separationspositioned at end region 34, but are equally applicable to end region32.

As detailed hereinbefore, an interior material separation extendingvertically through dilator 10 including the resilient layer, may becontained entirely within the peripheral edges of resilient member 22(or a component thereof) or extend inward from a peripheral edgethereof. Said material separation may allow formation of a flap capableof separating or vertically protruding, in part, from the resilientlayer. Said separation or vertical protrusion may also change, at leastin part, the angle of spring biasing forces of resilient member 22,while also allowing spring biasing forces to continue along a furtherextent of the resilient member or component. By virtue of extendingvertically through the resilient member without severing its entirewidth, said interior material separation reduces the total springbiasing force of resilient member 22, primarily from the point of saidseparation to the adjacent terminal end thereof. In this manner, anopposing pair of interior material separations may be spaced apart alongthe horizontal extent of resilient member 22 so as to redirect a greaterportion of total spring biasing force between the spaced apart pair anda corresponding lesser portion extending from each separation tocorresponding terminal ends 23 a and 23 b.

Accordingly, the type, number, and location of one or more interiorand/or material separations or pairs thereof, the configuration ofresilient member 22 and its corresponding resiliency, the relative sizeand shape of end regions 32 and 34, and the dynamic relationshipsbetween these various elements, all contribute to directing theresilient properties of dilator 10. Various examples thereof are givenin the preferred embodiments and discussed in more detail herein below.

As seen in FIGS. 1-15, an interior material separation comprises arelief cut, 24, located within each end region of truss 30. Relief cut24 preferably extends vertically through the cover, resilient and baselayers of dilator 10. FIG. 4 more particularly identifies relief cut 24having an outside edge, 26, which defines its width, and upper and lowerlong edges, 27 a and 27 b which define at least portions of its length.Outside edge 26 preferably corresponds to at least a portion of thenearest end edge 33 a or 33 b, respectively, of end regions 32 and 34.As discussed hereinbefore, each end region is shown as a mirror image ofthe other, so only one end region will be described withparticularity.). Outside edge 26 severs the entire width of resilientmember 22 laterally, preferably extending slightly past the upper andlower long edges thereof, before turning to upper and lower edges 27 aand 27 b. Upper and lower edges 27 a and 27 b extend inward preferablyabout 0.125″ in a direction parallel to upper and lower long edges ofresilient member 22. Relief cuts 24 redefine the functional length ofresilient member 22, as described hereinbefore, creating additional,substantially nonfunctional, resilient layer components.

FIGS. 5-7 show dilator 10 adhered to and flexed across the bridge of anose, 11, seen as a portion of a human face, 12. Relief cut 24 allowsformation of a flap, 25, at the redefined terminal ends of resilientmember 22, said flap capable of separating or vertically protruding, inpart, from respective end regions 32 and 34 of truss 30, and leaving acorresponding opening or gap, 28, from where it separates from the trusswhen dilator 10 is engaged to nose 11. The length of upper and loweredges 27 a and 27 b and the width of outside edge 26 of relief cut 24define the shape and dimensions of flap 25; its length being parallel tothe longitudinal extent of resilient member 22. Said length determinesin part the degree of said separation or vertical protrusion and thecorresponding change in angle, and thus transfer, of focused springbiasing forces from primarily peel forces and tensile forces intoprimarily shear forces, as discussed hereinbefore. Said transformedspring biasing forces are redistributed or imparted to tissue engagingsurfaces of dilator 10 extending in an area between gap 28 and thesurrounding peripheral edges of end region 32, as generally illustratedby directional arrows in FIG. 7. Relief cuts 24 are preferably spacedapart along the longitudinal extent of dilator 10, placed closer torespective end edges 33 a and 33 b than to intermediate region 36, so asto direct resilient properties along a greater, rather than lesser,longitudinal extent of dilator 10.

FIGS. 8-9 illustrate a variation of the nasal dilator of FIG. 1 in whichrelief cut 24 has a scalloped edge. FIG. 9 shows outside edge 26extending from respective upper and lower edges 27 a and 27 b,intersecting upper and lower long edges of resilient member 22 atsubstantially right angles thereto, before curving arcuately inward toform two scalloped portions of identical length and width. Therespective lengths of said scalloped portions may be defined by therespective lengths of upper and lower edges 27 a and 27 b and by thehorizontal location of the intersection between each scalloped portion.As more particularly illustrated in FIG. 9, portions of end edge 33 bcurve arcuately between upper and lower long edges of end region 34. Theapex of said arcuate curve preferably corresponds to the longitudinalaxis of dilator 10. Terminal end 23 b of resilient member 22 terminatesalong said apex. End edge 33 b may optionally correspond to thescalloped contour of outside edge 26.

FIG. 10 shows an alternative structure of relief cut 24 illustrated inFIG. 9 in which outside edge 26 forms scalloped portions of dissimilarshape. FIG. 10 indicates by bracketed broken lines the total length ofrelief cut 24 being defined by the respective lengths of upper and loweredges 27 a and 27 b and the contour of outside edge 26. The respectivewidths of scalloped portions thereof may be either identical ordissimilar, and are defined by the location of the intersectiontherebetween. The length and width of the scalloped portions of outsideedge 26 of relief cut 24 may result in slightly greater spring biasingforces imparted along the upper long edge of resilient member 22. Inaddition, the longer of the two scalloped portions tend to cause greaterseparation of flap 25 from gap 28, thus having a corresponding effect onspring biasing properties of dilator 10 as discussed hereinbefore.

FIGS. 11-12 illustrates another alternative structure of relief cut 24in which outside edge 26 forms a scalloped edge identical to a portionof corresponding end edge 33 b or 33 b. As more particularly illustratedin FIG. 12, outside edge 26 of relief cut 24 extends from upper andlower edges 27 a and 27 b, preferably intersecting upper and lower longedges of resilient member 22 at right angles thereto before forming asingle scalloped edge. Said scalloped edge conforms to a correspondingcenter portion of end edge 33 b of end region 34. The total length ofrelief cut 24, denoted by bracketed broken lines, is defined by thelength of upper and lower edges 27 a and 27 b, plus the horizontalextent of the scalloped portion of outside edge 26 extending toward endedge 33 b.

FIG. 12 further illustrates end edge 33 b having three portions situatedalong a common lateral plane, represented by broken lines. Said lateralplane may be optionally set at an oblique angle to the long axis ofdilator 10, corresponding approximately to the line where nose 11 meetsthe cheek of a face 12. The upper and lower of said three portions curvearcuately inward from the outside corners of upper and lower long edgesof end region 34, forming an exterior material separation comprising avalley, 38, at the intersections of respective upper and lower cornersof terminal end 23 b of resilient member 22. From the intersectionsformed by valleys 38, end edge 33 b curves outwardly again to form saidscalloped center portion. The apex of said center portion corresponds tothe longitudinal axis of resilient member 22, with terminal end 23 bthereof terminating along said scalloped center portion.

FIGS. 13-14 illustrate a combination of interior and exterior materialseparations in accordance with the present invention. FIG. 13 shows endedges 33 a and 33 b having scalloped portions which correspondsubstantially to terminal ends 23 a and 23 b of a pair of parallel,spaced apart, resilient members 22. Said terminal ends define thelongitudinal extent of dilator 10. A pair of interior materialseparations comprising relief cuts 24 are placed in a spaced apartrelationship in opposing end regions of truss 30, each relief cutforming a scalloped edge across the width of at least one of said pairof resilient members 22. FIG. 14 more particularly shows outside edge 26of relief cut 24 intersecting upper and lower long edges 27 a and 27 b,respectively, at oblique angles thereto. The shape of outside edge 26preferably corresponds to a corresponding portion of scalloped end edge33 b.

FIG. 14 further illustrates a pair of exterior material separationscomprising upper and lower back cuts, 37 a and 37 b, extendingvertically through at least the cover layer of dilator 10 and inwardfrom end edge 33 b. Each back cut is positioned at the intersection of acorresponding valley 38, adjacent and parallel to the upper and lowerlong edges of at least one resilient member 22. This arrangement definesa horizontal protrusion at the end portions of said one resilientmember. Lower back cut 37 b forms a separation between said horizontalprotrusion and a corresponding lower extension, 35 b. Extension 35 b mayoptionally extend horizontally beyond terminal end 23 b, and thus mayfurther define the longitudinal extent of dilator 10.

The interior material separation positioned in end region 34 may allowformation of a flap 25 at the redefined terminal ends of upper resilientmember 22, capable of separating or vertically protruding, in part, fromtruss 30 when dilator 10 is flexed across the nose. Similarly, thehorizontal protrusion defined by upper and lower back cuts 37 a and 37 bis also capable of separating or protruding vertically, in part, fromthe truss when the dilator is flexed across the nose of a wearer. Ineach case the material separation changes the angle, in part, of focusedspring biasing forces, transforming said forces as describedhereinbefore. With respect to the interior material separation, saidtransformed forces are imparted to the end region in general. Withrespect to said exterior material separations, said transformed forcesare imparted, at least in part, to extension 35 b.

The parallel spaced apart resilient members 22 may be of like ordissimilar width. A dynamic relationship exists not only between therespective spring biasing properties of multiple resilient members ofdissimilar widths, but also between the location of relief cuts 24, thelength(s) of relief cut(s) 24, back cuts 37 a and 37 b, and the combinedspring biasing forces generated by said pair of resilient members 22.Though all of these elements are shown as symmetric pairs, it will beobvious to the skilled man that said elements may be resized, recombinedor omitted.

FIG. 15 illustrates an alternative end region structure to that shown inthe embodiment of FIG. 14, in which relief cut 24 extends across saidpair of resilient members 22. Respective scalloped portions of outsideedge 26 extend across the width of each resilient member. End edge 33 bhas three portions situated along a common lateral plane. Said plane isshown perpendicular to the long axis of dilator 10, but may beoptionally situated at an oblique angle thereto, correspondingapproximately to the line where the nose meets the cheek. The upper andlower of said three portions curve arcuately inward from the outsidecorners of upper and lower long edges of end region 34, forming valley38 at intersections adjacent above and below respective upper and lowercorners of terminal ends 23 b of said pair of resilient members 22. Fromsaid intersections end edge 33 b curves outwardly again to form saidscalloped center portion. The apex of said center portion corresponds tothe longitudinal axis of the pair of resilient members 22, with terminalends 23 b thereof terminating along said scalloped center portion.

FIGS. 16-17 illustrate another combination of interior and exteriormaterial separations in accordance with the present invention. End edges33 a and 33 b form a scalloped portion corresponding to respectiveterminal ends 23 a and 23 b of resilient member 22. The distance betweensaid terminal ends represents the longitudinal extent of dilator 10.Exterior material separations comprising upper and lower notches, 39 aand 39 b, are positioned parallel to and adjacent upper and lower longedges of resilient member 22. Notches 39 a and 39 b extend verticallythrough the base and cover layers of dilator 10, and inward from endedges 33 a and 33 b, respectively. Notches 39 a and 39 b defineintersections between said scalloped portion of end edges 33 a and 33 band upper and lower tab extensions 35 a and 35 b, respectively, of endregions 32 and 34. Tab extensions 35 a and 35 b may optionally extendto, or beyond, said scalloped portions, the latter thus further definingthe longitudinal extent of dilator 10. As more particularly illustratedin FIG. 17, said scalloped mid portion of end edge 33 b and notches 39 aand 39 b define a horizontal protrusion, also capable of separating inpart from the end region 34, as discussed hereinbefore. Said separationchanges the angle, at least in part, of spring biasing forces, andshifts and transforms said forces, similarly as described with respectto FIG. 13, imparting said transformed forces to both upper and lowertab extensions 35 a and 35 b of end region 34.

The dilator of FIGS. 16-17 further includes an opposing pair of interiormaterial separations each comprising an elongated opening, 29, extendingvertically through at least resilient member 22 and contained within thewidth thereof. Opening 29 may be optionally formed before assembly ofthe vertical laminate of dilator 10, or (as shown) formed as dilator 10is die cut from a continuous material laminate. Opening 29 has agradient increase in width along its length, extending horizontally frominward to outward, which defines corresponding adjacent upper and lowerportions of resilient member 22 having a gradient reduction in width.Opening 29 may be of any size or shape contained within the width ofresilient member 22. Each of the opposing pair thereof is preferablypositioned horizontally between the lateral centerline of truss 30 andrespective end edges 33 a and 33 b.

The relative width of opening 29 compared to the width of resilientmember 22 thereat, together with the distance between said opposing pairof openings 29 defines a dynamic relationship, which determines springbiasing forces generated between said openings and extending beyond eachopening to corresponding terminal ends 23 a and 23 b, respectively, ofresilient member 22. Another dynamic relationship exists between theconfiguration of interior material separations, openings 29, and theexterior material separations at respective end edges 33 a and 33 b.

FIGS. 18-19 illustrate an embodiment of dilator 10 in accordance withthe present invention in which the end regions of truss 30 include upperand lower bifurcated end region portions. In addition, resilient member22 includes a plurality of component spring fingers, 21, diverging andextending outward from a common center. Said common center is preferablyaligned with the lateral and longitudinal centerlines of intermediateregion 36. Spring biasing forces generated by the resilient layer ofdilator 10 are gradiently reduced, at least in part, in the course ofbeing directed to spring fingers 21. Upper and lower fingers 21 havinguniform gradient widths, but may optionally curve, be asymmetric, andmay be equidistant or of varying distance from said common center. Asnoted hereinbefore, divergent or asymmetric dilator features can providedisparate spring biasing forces. Fingers 21 may be further defined by aslit, 31, extending inward from the point where upper fingers divergefrom lower fingers.

Fingers 21 extend into corresponding bifurcated portions of end regions32 and 34. Terminal ends 23 a and 23 b of upper fingers 21 extend to,and conform with, portions of end edges 33 a and 33 b thereat. Terminalends 23 a and 23 b of lower fingers 21 extend short of end edges 33 aand 33 b. Spring fingers 21 and slits 31 of resilient member 22 areconfigurations preferably made prior to assembling the vertical laminateof dilator 10. The divergent extent of spring fingers 21 determines thelateral spread of spring biasing forces at end regions 32 and 34. Thegradient width and the length of each spring finger 21, defined in partby the length of slit 31, determines the gradient reduction in springbiasing forces along the longitudinal and lateral extents of resilientmember 22. In addition, the divergent end region structure of dilator 10provides additional lateral, torsional, flexibility primarily at the endregions, allowing dilator 10 to simultaneously effect dilation of nasalouter wall tissues adjacent both the nasal valve and nasal vestibule.

As more particularly illustrated in FIG. 19, end edge 33 b has one oftwo exterior material separations comprising a valley, 38′, forming theintersection between said upper and lower bifurcated end regionportions. A second exterior material separation comprising a slit, 31′,extends inward from the terminus of valley 38′ preferably along thelongitudinal axis of truss 30, corresponding to slit 31 in resilientmember 22. Slit 31′ preferably extends short of resilient member 22.

As further illustrated in FIG. 19, upper bifurcated end region portionsinclude relief cut 24 extending across the width of upper spring finger21. Another relief cut 24 is positioned outboard and adjacent terminalend 23 b of lower spring finger 21, corresponding to the shape of saidterminal end. Relief cuts 24 have upper and lower edges 27 a and 27 b,respectively, defining their length and extending parallel to the longedges of spring finger 21. Outside edge 26 preferably extends beyondupper and lower long edges of spring finger 21, substantially followingthe contour of the corresponding end edge 33 b. Relief cuts 24 allowformation of a flap, as described hereinbefore, capable of separating orvertically protruding, in part, when dilator 10 is flexed across thenose; said separations or vertical protrusions changing the angle, inpart, of spring biasing forces, as described hereinbefore, transformingsaid forces and imparting them, at least in part, to tissue engagingsurface areas extending outward to corresponding peripheral edges ofsaid bifurcated end region portions of truss 30.

FIGS. 20-21 illustrate an embodiment in accordance with the presentinvention where enlarged end portions, 20, of resilient member 22,formed as a modification prior to assembling the vertical laminate ofdilator 10, correspond generally to the shape of end regions 32 and 34of truss 30. Resilient member end edges 23 a and 23 b extend to, andconform with, portions of end region end edges 33 a and 33 b,respectively. As more particularly illustrated in FIG. 21, valley 38′extends inward from said end edge, simultaneously bifurcating endregions 32 and 34, as well as enlarged end portions, 20, of resilientmember 22. Said bifurcation forms spring fingers, 21′, in resilientmember 22 and upper/lower bifurcated end region portions having commoninside long edges therewith. Valley 38′ may be configured to gradientlyreduce the width of at least one spring finger 21′. Depending upon thedimensional relationship between the width of enlarged end portions 20and the length and width of valley 38′, said bifurcation may laterallyspread, and/or reduce, or gradiently reduce the spring biasing forces ofdilator 10 primarily at end regions 32 and 34. This divergent end regionstructure provides additional lateral torsional flexibility primarily atthe end regions of truss 30, allowing dilator 10 to simultaneouslyeffect dilation of nasal outer wall tissues adjacent both the nasalvalve and nasal vestibule.

FIGS. 22-23 illustrate an embodiment of dilator 10 in accordance withthe present invention in which enlarged end portions 20 of resilientmember 22 correspond substantially to the peripheral shape of therespective end regions of truss 30 and are positioned substantially atthe lateral and longitudinal axes thereof. Resilient member terminalends 23 a and 23 b thus extend short of, but conform with, end regionend edges 33 a and 33 b, respectively, of said end regions. Said endedges form upper and lower horizontal protrusions extending to a commonlateral plane, represented by broken lines, perpendicular to the longaxis of dilator 10. Said horizontal protrusions define the longitudinalextent of dilator 10.

As more particularly illustrated in FIG. 23, relief cut 24 is positionedadjacent terminal end 23 b of resilient member 22, preferably as closelyas practicable thereto. Its upper and lower edges 27 a and 27 b extendparallel to, and at least partway along, upper and lower long edges ofenlarged end portions 20. Outside edge 26 corresponds generally to thecontour of terminal end 23 b of resilient member 22. The width ofenlarged end portion 20 spreads spring biasing forces generated byresilient member 22, at least in part, laterally across end region 34.Relief cut 24 may cause the terminal end of resilient member 22 toseparate or vertically protrude from the truss when dilator 10 is flexedacross the nose, with the corresponding effect thereat as describedhereinbefore, transforming said forces and imparting them, at least inpart, to tissue engaging surface areas extending outward and beyondrelief cut 24 to corresponding peripheral edges of end region 34.

FIGS. 24-34 illustrate variations of an embodiment of dilator 10 inaccordance with the present invention in which resilient member 22 has agradiently reduced width which provides reduced spring biasing forceextending horizontally from the lateral centerline of truss 30 torespective terminal ends 23 a and 23 b. The mid portion of resilientmember 22 preferably has a constant width representing its widestportion. In the embodiment of FIGS. 24 and 25, terminal ends 23 a and 23b extend short of respective lateral end edges 33 a and 33 b of truss30. In the embodiment of FIGS. 26-34, said terminal ends extend to, andconform with, portions of said respective lateral end edges.

The embodiment of dilator 10 shown in FIGS. 24-25 shows relief cut 24placed outboard and adjacent terminal ends 23 a and 23 b of resilientmember 22. Relief cut 24 extends around and corresponds to the peripheryof each said terminal end, substantially as described with respect tothe embodiment of FIGS. 22 and 23. As described hereinbefore, relief cut24 may cause the terminal end of resilient member 22 to separate orvertically protrude from the truss when dilator 10 is flexed across thenose, with the corresponding effect thereat as described hereinbefore,transforming said forces and imparting them, at least in part, to tissueengaging surface areas extending outward and beyond relief cut 24 tocorresponding peripheral edges of end region 34.

As further illustrated in FIG. 24, dilator 10 includes two elongatedopenings 29 extending vertically through at least the resilient layer,similar to that described with respect to openings 29 in the embodimentof FIGS. 16 and 17. Opening 29 is horizontally positioned at theapproximate intersection of intermediate region 36 and respective endregions 32 and 34 of truss 30. In this instance, opening 29 has itswidest end placed to the inside, with upper and lower long edgesparallel to the upper and lower long edges of resilient member 22.Opening 29 thus defines upper and lower portions of resilient member 22adjacent thereto having a constant width. The closed end of opening 29may optionally include a slit extending to corresponding terminal end 23a or 23 b of resilient member 22.

FIGS. 26-28 illustrate an alternative structure in which the resilientand base layers of dilator 10 converge toward common upper and lowerlong edges at intermediate region 36. Two opposing relief cuts 24 extendvertically through the truss, including the resilient layer thereof,severing a portion of the width of resilient member 22. Cover member 18comprises two components each corresponding substantially to respectiveend regions 32 and 34 of truss 30, thus leaving portions of theresilient and base layers uncovered. A single interior materialseparation comprising elongated opening 29 is positioned at the lateraland longitudinal centerlines of the truss, extending vertically at leastthrough resilient member 22. Opening 29 also serves as an aid foraligning dilator 10 to the bridge of nose 11. The peripheral shape ofresilient member 22 and opening 29 may be formed prior to assembling theconstituent layers of dilator 10.

Opening 29 effectively reduces the spring biasing strength of resilientfrom that which would otherwise be generated at its widest portion.Accordingly, there is a dynamic relationship between the size of opening29 and the dimensions of resilient member 22, said dynamic relationshipcontributing to the direction of spring biasing properties of dilator10. Opening 29 and relief cuts 24 direct spring biasing propertiesextending outward horizontally from intermediate region 36 when dilator10 is in use on nose 11. Relief cut 24 includes a scalloped outside edge26 which allows formation of a partial flap capable of separating orvertically protruding, in part, from resilient member 22 when thedilator is flexed across the nose of a wearer. The degree of verticalprotrusion thereat is limited, however, the dynamic relationship betweenthe size, shape and position of opposing relief cuts 24, relative to thedimensions of resilient member 22, determine the distribution of focusedspring biasing forces therebetween, as well as those forces extendingbeyond each relief cut 24 toward respective terminal ends 23 a and 23 bwhen dilator 10 is in use on nose 11. Said terminal ends extend to, andconform with, a scalloped mid portion of end edges 33 a and 33 b oftruss 30.

As more particularly illustrated in FIG. 27, upper edge 27 a of reliefcut 24 extends parallel to upper long edge of resilient member 22.Outside edge 26 intersects the upper long edge of resilient member 22 ata right angle thereto before curving arcuately outward to form scallopededge 26. The mid portion of end edge 33 b is defined by upper and lowerback cuts 37 a and 37 b, positioned adjacent upper and lower long edgesof resilient member 22. Back cuts 37 a and 37 b extend verticallythrough the base and cover layers and inward from corresponding valley38 at end edge 33 b, similarly as described with respect to theembodiments of FIGS. 13-14 and 16-17. Together with back cuts 37 a and37 b, said scalloped mid portion of end edge 33 b defines a horizontalprotrusion, also capable of separating in part from end region 34. Saidseparation changes the angle, at least in part, of spring biasing forcesextending beyond relief cuts 24, and shifts and transforms said forces,as described hereinbefore, redistributing said transformed forces, atleast in part, to upper and lower tab extensions 35 a and 35 b.

FIGS. 29-32 illustrate another alternative structure of dilator 10 inwhich opposing pairs of interior and exterior material separations,together with the configuration of the resilient layer, direct theresilient properties of dilator 10. FIG. 29 shows interior materialseparations comprising opposing relief cuts 24 extending verticallythrough dilator 10. Relief cuts 24 are positioned at opposite ends ofthe intermediate region of truss 30 substantially at the intersectionsbetween intermediate region 36 and respective end regions 32 and 34thereof. Relief cuts 24 each form a flap capable of separating orvertically protruding, in part, from the resilient layer when thedilator is flexed across the nose, and may be any size contained withinthe peripheral edges of resilient member 22, with the correspondingeffect thereat as described hereinbefore. The relative sizes of opposingrelief cuts 24 together with the gradiently reduced width of resilientmember 22 contribute to the overall gradient reduction of spring biasingproperties of the resilient layer extending horizontally fromintermediate region 36 to respective end regions 32 and 34. Dependingupon the lateral extend of outside edge 26 and the length of upper andlower long edges 27 a and 27 b, opposing relief cuts 24 may alsodynamically direct a greater amount of total spring biasing force to thehorizontal extent therebetween and a lesser amount extending beyond eachrelief cut 24 to respective end edges of truss 30.

FIG. 30 more particularly illustrates said exterior material separationscomprising upper and lower back cuts 37 a and 37 b, extending inwardfrom a corresponding valley 38 at end edge 33 b adjacent upper and lowerlong edges of resilient member 22, as described hereinbefore. Togetherwith back cuts 37 a and 37 b, the scalloped mid portion of end edge 33 bdefines a horizontal protrusion, also capable of separating in part fromthe end region 34 when dilator 10 is flexed across a nose 11,redistributing transformed spring biasing forces to tab extensions 35 aand 35 b of end region 34 as described hereinbefore. FIG. 31 moreclearly illustrates separation flaps 25 formed by said interior andexterior material separations, separating or vertically protruding, inpart, from end regions 32 and 34 of truss 30, directing resilientproperties thereof as described hereinbefore.

As illustrated in FIG. 32, dilator 10 includes means to prevent one ormore material separations from separating or vertically protruding fromthe truss. An additional cover layer component, 19, may be optionallyapplied by a user over one or more of said interior or exterior materialseparations, effectively hindering or preventing at least a portion ofits separation or vertical protrusion from truss 30. End regioncomponent 19 preferably corresponds in shape to at least a portion ofeither end region of truss 30, and may, for example, be peeled by handfrom a sheet containing a plurality thereof (i.e., in the same mannerone would peel a self-adhesive label from a continuous sheet thereof)and placed on top of a corresponding portion of cover member 18,preferably centered over one or more said material separation(s).Component 19 may also be configured such that its peripheral edgesextend beyond the peripheral edges of said horizontal portion of covermember 18, as shown, effectively allowing the user to extend or increasethe tissue engaging surface area of dilator 10. It will be obvious tothe skilled man in the art that end region component 19 may be added tovirtually any of the preferred embodiments illustrated herein.

FIGS. 33-34 illustrate an embodiment of dilator 10 in accordance withthe present invention in which an opening and relief cuts are combinedinto a single element. Opening 29 extends vertically through andlaterally across the upper and lower long edges of resilient member 22.The outside edge of opening 29 preferably conforms to corresponding endedge 33 a or 33 b of truss 30 which, in the present example, is angledinward in a straight line between upper and lower corners of the longedges of dilator 10, said angle corresponding approximately to the linewhere the nose meets the cheek. Opening 29 includes upper and lowerrelief cuts, 27 a′ and 27 b′, extending inward from the respective upperand lower inside corners thereof, adjacent and parallel to the upper andlower long edges of resilient member 22. Relief cuts 27 a′ and 27 b′allow formation of a flap at the redefined terminal ends of resilientmember 22, said flap capable of separating or vertically protruding, inpart, from the truss when dilator 10 is flexed across the nose, with thecorresponding effect thereat as described hereinbefore.

With respect to FIGS. 24-34, and as described hereinbefore, a dynamicrelationship exists between the configuration of resilient member 22 (inthese particular embodiments, the gradient tapering of its upper andlower long edges), and a combination of interior and exterior materialseparations, plus additional, optionally user-applied components, eachand all contributing to the direction of resilient properties of dilator10.

The dilator of FIGS. 33-34 further includes a material formation, 41 aand 41 b, located along the upper and lower long edges of intermediateregion 36 midway between end edges 33 a and 33 b. Formation 41 acomprises an upper protrusion and a corresponding lower indentation 41b. Material formation 21 may be of any suitable size or shape, and maybe symmetric, asymmetric, straight, curved or gradient. Formation 41forms a positioning aid for aligning dilator 10 to a nose 11. Whendilator 10 is applied to the nose, one or more formations 41 are meantto be aligned with the vertical center line of the bridge of the nose bythe user, thus aiding precise horizontal placement of dilator 10 to nose11. Alternatively, one or more material formation 41 may be made withinthe periphery of truss 30, and need not extend through all layersthereof so long as they are visible, and allow the user to align thelateral center of dilator 10 with the vertical center line of the bridgeof nose 11.

The foregoing descriptions and illustrations are intended to reveal thescope and spirit of the present invention and should not be interpretedas limiting, but rather as illustrative of the inventive concepts andtechniques thereof. Skilled men in the art to which the presentinvention is directed will appreciate that insubstantial changes,modifications and alterations of the present disclosure may be made andeach such insubstantial change, modification and alteration are intendedto be fully covered hereby.

I claim:
 1. A nasal dilator comprising a laminate of vertical layersincluding a resilient member secured to at least one of a base layer orcover layer; the resilient member having a gradiently reduced widthextending from a widest portion to a narrowest portion, the widestportion and the narrowest portion centered substantially along alongitudinal centerline of the dilator such that opposing portions ofresilient member outer long edges define a progressively narrower widthextending between the widest and narrowest portions, the at least one ofa base layer or cover layer substantially defining a periphery of thedilator; the dilator further comprising a plurality of shaped materialseparations including a pair of opposing shaped openings extendingvertically through an entire thickness of the laminate, the openingslocated inboard peripheral edges of the resilient member substantiallyequidistant between a lateral centerline and a lateral end edge of thedilator substantially along the longitudinal centerline thereof, theopenings contained wholly within said peripheral edges.
 2. The nasaldilator of claim 1 wherein the resilient member extends short of alateral end edge of the dilator, the plurality of shaped materialseparations further comprising: a relief cut extending verticallythrough the at least one of a base layer or cover layer, the relief cutpositioned outward from and adjacent to a resilient member terminal end,and inboard from and adjacent to the at least one dilator lateral endedge, the relief cut corresponding generally to a shape of saidresilient member terminal end.
 3. The nasal dilator of claim 1, furthercomprising: a user-applied component extending over at least one of thepair of opposing relief cuts for preventing, at least in part, therelief cut from separating or vertically protruding when the dilator isin use.
 4. The nasal dilator of claim 1, wherein the plurality of shapedmaterial separations comprise a pair of opposing shaped relief cuts anda separate central opening, wherein the opposing shaped relief cutsextend vertically through an entire thickness of at least the resilientmember inboard peripheral edges thereof, each relief cut positionedsubstantially equidistant between a lateral centerline and a lateral endedge of the dilator substantially along the longitudinal centerline; andwherein the central opening extends vertically though an entirethickness of at least the resilient member, the central openingpositioned substantially at the lateral and longitudinal centerlines ofthe nasal dilator.